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CLIMANOR is a brand name for Medroxyprogesterone (also known as Medroxyprogesterone Acetate). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dysfunctional uterine bleeding, secondary amenorrhoea, mild to moderate endometriosis. In combination with an oestrogen product for hormone replacement therapy (HRT) for oestrogen deficiency symptoms in peri- and post-menopausal women.
Verbatim from this product's MHRA label. Tap a section to expand.
Administration:
Oral Dysfunctional uterine bleeding: 5 - 10 mg a day for 5 - 10 days commencing on the assumed or calculated sixteenth to twenty first day of the cycle, for two consecutive cycles. When bleeding occurs from a poorly developed proliferative endometrium, oestrogen therapy in conjunction with medroxyprogesterone acetate in doses of 5 - 10 mg a day for 12 days can be administered.
Secondary amenorrhoea: 5 - 10 mg a day for 5 - 10 days, beginning on the assumed or calculated sixteenth to twenty first day of the cycle, for three consecutive cycles. In amenorrhoea associated with a poorly developed proliferative endometrium, oestrogen therapy in conjunction with medroxy- progesterone acetate in doses of 5 - 10 mg for 12 days can be administered.
Mild to moderate endometriosis: 10 mg three times a day for 90 consecutive days beginning on the first day of the menstrual cycle. Breakthrough bleeding, which is self-limiting, may occur. No additional hormonal therapy is recommended for the management of this bleeding.
4). Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. 4) should be used. Missed doses If any dose is forgotten the patient should be advised to take it as soon as they remember.
However, if it is time for the next dose, patients should be advised not to take the missed dose but to continue to take the tablets as prescribed until the end of each course. A missed dose may increase the likelihood of break-through bleeding and spotting
The following medical events are occasionally associated with the use of progestogens: Breasts - Breast tenderness or galactorrhoea, breast cancer (see below). Genito-urinary System - Patients with intact uteri taking progestogens for endometrial safety may also report vaginal bleeding.
CNS - nervousness, insomnia, somnolence, fatigue, dizziness, depression (including pre-menstrual like depression), and headache. Skin - urticaria, pruritus, rash, acne, hirsutism and alopecia have been reported occasionally. Anaphylactoid-like reactions are rare.
Gastrointestinal – Nausea and indigestion have been noted in some subjects. Miscellaneous - weight gain has been noted in some subjects. e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among HRT users than among non-users.
4) Breast Cancer According to evidence from a large number of epidemiological studies and one randomised placebo-controlled trial, the Women’s Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users.
40), respectively. For oestrogen plus progestogen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with oestrogens alone. 68). 6 years of use of oestrogen-progestogen combined HRT (CEE + MPA) in all users compared with placebo.
The absolute risks calculated from the MWS and the WHI trial are presented below:
The MWS has estimated, from the known average incidence of breast cancer in developed countries, that: • For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.
5) for 5 years’ use • between 3 and 7 (best estimate = 5) for 10 years’ use. o For users of oestrogen plus progestogen combined HRT, • between 5 and 7 (best estimate = 6) for 5 years’ use • between 18 and 20 (best estimate = 19) for 10 years’ use.
a) Medical examination/follow-up Before initiating or reinstituting therapy, a complete personal and family medical history should be taken. 4) for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below). Women should be encouraged to participate in the national breast cancer screening programme (mammography) and the national cervical screening programme (cervical cytology) as appropriate for their age.
Investigations, including mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. b) Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
It should be taken into account that these conditions may recur or be aggravated during treatment with oestrogen/progestogens, in particular: - Leiomyoma (uterine fibroids) or endometriosis; - A history of, or risk factors for, thromboembolic disorders (see below); - Risk factors for oestrogen dependent tumours, eg 1st degree heredity for breast cancer; - Hypertension; - Liver disorders (eg liver adenoma); - Diabetes mellitus with or without vascular involvement; - Cholelithiasis; - Migraine or severe headache; - Systemic lupus erythematosus; - A history of endometrial hyperplasia (see below); - Epilepsy; - Asthma; - Otosclerosis.
c) Reasons for immediate withdrawal of therapy Therapy should be discontinued when a contra-indication is discovered and in the following situations: - Jaundice or deterioration in liver function; - Significant increase in blood pressure; - New onset of migraine-type headache; - Pregnancy.
g. angina, myocardial infarction); Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal; Known hypersensitivity to the active substance or to any of the excipients; Porphyria; When used as part of an oestrogen-containing HRT regimen, the following also apply: Known or suspected oestrogen dependent malignant tumours (eg endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to oestrogen-progestogen combined HRT (CEE + MPA) per 10,000 women years. According to calculations from the trial data, it is estimated that: o For 1000 women in the placebo group, • about 16 cases of invasive breast cancer would be diagnosed in 5 years.
o For 1000 women who used oestrogen + progestogen combined HRT (CEE + MPA), the number of additional cases would be • between 0 and 9 (best estimate = 4) for 5 years’ use. 4). Endometrial cancer In women with an intact uterus, the risk of endometrial hyperplasia and endometrial cancer increases with increasing duration of use of unopposed oestrogens.
According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT, about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65. Depending on the duration of treatment and oestrogen dose, the reported increase in endometrial cancer risk among unopposed oestrogen users varies from 2-to 12-fold greater compared with non-users.
Adding a progestogen to oestrogen-only therapy greatly reduces this increased risk.
d) General considerations Women of child bearing potential should be advised to adhere to non- hormonal contraceptive methods. Whether administered alone or in conjunction with oestrogens, Climanor should not be employed in patients with abnormal uterine bleeding until a definite diagnosis has been established and the possibility of genital malignancy eliminated.
Rare cases of venous thrombo-embolism have been reported with the use of Climanor. Causality has not been established. (e) Venous thromboembolism). e) Use as HRT For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.
In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk. 8). The addition of a progestogen for at least 12 days per cycle in non-hysterectomised women greatly reduces this risk.
25 mg and patches >50ug/day the endometrial safety of added progestagens have not been studied. Break-through bleeding and spotting may occur during the first months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
8). For all HRT, an excess risk becomes apparent within a few years of use and increases with duration of intake but returns to baseline within a few (at most five) years after stopping treatment. In the MWS, the relative risk of breast cancer with conjugated equine oestrogens (CEE) or estradiol (E2) was greater when a progestogen was added, either sequentially or continuously, and regardless of type of progestogen.
There was no evidence of a difference in risk between the different routes of administration. In the WHI study, the continuous combined conjugated equine oestrogen and medroxyprogesterone acetate (CEE + MPA) product used was associated with breast cancers that were slightly larger in size and more frequently had local lymph node metastases compared to placebo.
HRT, especially oestrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer. e. deep vein thrombosis or pulmonary embolism. One randomised controlled trial and epidemiological studies found a two to threefold higher risk for users compared with non-users.
For non-users, it is estimated that the number of cases of VTE that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 8 per 1000 women aged between 60-69 years. It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5 year period will be between 2 and 6 (best estimate = 4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate = 9) per 1000 women aged 60-69 years.
The occurrence of such an event is more likely in the first year of HRT than later. Generally recognised risk factors for VTE include a personal history or family history, severe obesity (Body Mass Index > 30 kg/m2) and systemic lupus erythematosus (SLE).
There is no […]